Label: YES TO GRAPEFRUIT MOISTURIZER WITH SPF15- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 26, 2013

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  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredients

    Zinc Oxide (3.2%), Titanium Dioxide (2.9%)

  • Purpose

    Sunscreen

    Uses  Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn

  • Warnings:

    For external use only • When using this product, avoid contact with eyes • If contact occurs, rinse with water to remove • Stop use and ask a doctor if rash or irritation develops and lasts • Keep out or reach of children; if swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Apply liberally 15 minutes before sun exposure.  Ues a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor.

    Sun Protection Measure Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses.

  • Inactive Ingredients

  • Principal display panel

    Image Components

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  • INGREDIENTS AND APPEARANCE
    YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.2 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GUAR GUM (UNII: E89I1637KE)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorGRAPEFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0317-141 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/14/2012
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0317)
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